Latest Regulatory Updates

The FDA has published summaries of patient listening sessions held to gather input on various topics related to biologics, including multiple myeloma and hematologic malignancies, intended to inform future policy decisions.

This FDA announcement provides updates on various topics related to biologics, including guidance documents, draft guidance for biosimilars, and information regarding the implementation of the Biologics Acceptance Review (BAR) system.

The FDA has published Standard Operating Procedures (SOPPs) providing detailed guidance on various aspects of biologics manufacturing and testing to ensure product quality and compliance with regulations.

This guidance from the MHRA details how to apply for a variation to a marketing authorization for medicines in the UK, outlining requirements and processes for modifications to existing approvals.

The MHRA has announced the parallel import licences that will be granted in 2025, outlining specific products and associated assessment timetables.

This document details marketing authorisations granted by the MHRA in 2025, providing information on the products approved and their associated assessment timetables.

This guidance from the MHRA explains how Safety Public Assessment Reports (SPARs) are produced for certain marketing authorisations, outlining their purpose, content, and availability to the public.

The MHRA has granted exceptional use authorisations to three medical devices – Ocumont Eye Ointment, a wound dressing and an implantable device - to address critical shortages due to supply chain disruptions.

This FDA guidance outlines innovative clinical trial designs, including adaptive designs and master protocols, to facilitate development of cellular and gene therapy products when studying small patient populations.

The FDA has approved FluMist Quadrivalent, a live attenuated influenza vaccine (LAIV) for active immunization of children 2 through 17 years of age against influenza types A and B.

The FDA webpage outlines the agency's evolving approach to incorporating real-world evidence (RWE) into regulatory decision-making for biologics, including its use in clinical trial design and postmarket surveillance.

This document provides an overview of the MHRA's Early Access to Medicines Scheme (EAMS), which allows patients with high unmet needs access to innovative medicines before they receive full marketing authorization in the UK.

This MHRA guidance provides information and links to find product-specific details, including prescribing information, packaging leaflets, and product licensing documentation, for medicines authorized in the UK.

Ilona Reischl has been re-elected as the chair of the European Medicines Agency's (EMA) Committee for Advanced Therapies, ensuring continued leadership in evaluating gene therapy, cellular therapy, and tissue-engineered products.

This concept paper outlines the EMA's plans to develop a guideline exploring the potential use of owner assessment as an efficacy parameter in certain clinical settings, particularly for innovative medicines and advanced therapies.

The European Medicines Agency (EMA) has released a draft guideline, Revision 2, providing recommendations for the development and authorization of veterinary medicinal products intended to control Varroa destructor parasitosis in bees.

This draft guideline from the EMA outlines general requirements for evaluating the efficacy of ectoparasiticides intended for use in veterinary medicine, providing a framework for sponsors preparing submissions.

The European Medicines Agency (EMA) has released a draft guideline revising the requirements for combined vaccines and associations of immunological veterinary medicinal products, providing updated recommendations for developers.

This reflection paper from the EMA provides guidance on the investigation and assessment of cardiovascular safety risks associated with anticancer medicinal products, outlining expectations for sponsors regarding data collection and evaluation.

The International Council for Harmonisation (ICH) has published the minutes from its 51st Management Committee and Assembly meetings, detailing discussions and decisions related to ongoing harmonization efforts in pharmaceutical technical guidelines.